Exhaust collection bag for cryogenic treatment

ABSTRACT

An exhaust collection bag for cryogenic treatment is described herein and may generally comprise a first layer and a second layer attached along a periphery and forming an enclosed volume. The periphery defines four radiused corners and an extension member. A tubing connector may be positioned along the first layer and extend through the first layer and may also be located along a centerline of the first layer and in proximity to a bottom edge of the first layer. A drain closure may also be positioned along the first layer and located away from the centerline and in proximity to the bottom edge.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 15/288,766 filedOct. 7, 2016, which claims the benefit of priority to U.S. ProvisionalApplication No. 62/239,139 filed Oct. 8, 2015, each of which isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to medical devices. In particular, thepresent invention relates to methods and apparatus for collectingexhaust gases generated from the cryoablative treatment of tissueregions.

BACKGROUND OF THE INVENTION

In the last few decades, therapeutic intervention within a body cavityor lumen has developed rapidly with respect to delivery of energy viaradiofrequency ablation. While successful in several arenas,radiofrequency ablation has several major downsides, includingincomplete ablation, frequent lack of visualization during catheterinsertion, potential for overlap during treatment (with some areasreceiving twice as much energy as other areas), charring of tissues andrequirements for frequent debridement, frequent requirements foradditional doses of energy after debridement, and potential perforationof the body cavity or lumen due to the rigidity of the RF electrodes.

The current state of the art would benefit from minimally invasivedevices and methods which deliver thermal energy to a desired area orextract energy from a desired area, in a consistent, controlled mannerthat does not char or inadvertently freeze certain tissues or createexcessive risk of unwanted organ or lumen damage.

SUMMARY OF THE INVENTION

Generally, devices for delivering controlled treatment may comprise anelongate probe having a distal tip and a flexible length, at least oneinfusion lumen positioned through or along the elongate probe, whereinthe infusion lumen defines one or more openings along its length, aliner expandably enclosing the probe, an inflow reservoir or canistervalve fluidly coupled with a reservoir or canister containing acryoablative agent, a modulation control unit fluid coupled with theinflow reservoir or canister valve and in fluid communication with theat least one infusion lumen, and a warming element thermally coupledwith the reservoir or canister.

One method for utilizing the treatment assembly for cryoablativelytreating tissue, e.g., uterine tissue, may generally comprisingmonitoring a temperature or pressure of the reservoir or canistercontaining a cryoablative agent, maintaining the temperature of thereservoir or canister at a predetermined level, positioning an elongateprobe into a body lumen to be treated, expanding a liner enclosing theprobe into contact against the body lumen, and infusing a cryoablativeagent through a delivery lumen such that the cryoablative agent passesinto an infusion lumen, through one or more unobstructed openings, andinto contact against an interior of the liner.

In controlling or modulating the flow of the cryoablative agent, theinflow reservoir or canister valve which is fluidly coupled with thereservoir or canister may be utilized. Such a valve may generallycomprising a valve body, a reservoir interface extending from the valvebody and configured for fluidly coupling with the reservoir or canistercontaining the cryoablative agent, a modulation control interfacedefined along the body and configured for fluidly coupling to amodulation control interface, a valve stem seated within a valve stemchannel defined within the valve body, an inflow lumen defined throughthe valve body and extending between the reservoir interface and themodulation control interface, where the valve stem is movable between afirst position which obstructs the inflow lumen and a second positionwhich opens the inflow lumen, a venting lumen defined through the valvebody and extending between the reservoir interface and a vent opening,and a vent piston which is movable between a first position whichobstructs the venting lumen and a second position which opens theventing lumen. Alternatively, the valve stem may be configured toinclude three positions including a first position which obstructs theinflow lumen, a second position which opens the inflow lumen, and athird optional position which opens the venting lumen.

To facilitate the liner expanding and conforming readily against thetissue walls of the uterus, the liner may be inflated with a gas orliquid. Once the elongate shaft has been introduced through the cervixand into the uterus, the distal opening of the shaft may be positioneddistal to the internal os and the liner may be deployed either fromwithin the shaft or from an external sheath. The liner may be deployedand allowed to unfurl or unwrap within the uterus. The cooling probe maybe introduced through the shaft and into the liner interior. As thecryoablative agent (e.g., cryoablative fluid) is introduced into anddistributed throughout the liner interior, the exhaust catheter may alsodefine one or more openings to allow for the cryoablative fluid to ventor exhaust from the interior of the liner.

A coolant reservoir, e.g., nitrous oxide canister, may be fluidlycoupled to the handle and/or elongate shaft via a coolant valve whichmay be optionally controlled by the microcontroller. The coolantreservoir may be in fluid communication with the cooling probe assemblyand with the interior of the balloon. Additionally, an exhaust lumen incommunication with the elongate probe and having a back pressure valvemay also include a pressure sensor where one or both of the backpressure sensor and/or valve may also be in communication with themicrocontroller.

The reservoir or canister may be inserted into the reservoir housing andinto secure engagement with a reservoir or canister valve which may becoupled to the reservoir engagement control. The valve may be adjustedto open the reservoir or canister for treatment or for venting of thedischarged cryoablative fluid during or after treatment. An inflowmodulation control unit (e.g., an actuatable solenoid mechanism) may becoupled directly to the reservoir or canister valve and the cryoablativefluid line may be coupled directly to the modulation control unit andthrough the sheath and into fluid communication within the liner.

With the discharged cryoablative fluid in a completely gaseous state,the evacuating exhaust line may be vented to the surrounding environmentor optionally coupled to a scavenging system to collect the dischargedgas to limit exposure. Such scavenging collection systems mayincorporate features such as orifices or valves to prevent any vacuumapplied by the scavenging unit from interfering with the backpressurewithin the treatment device.

In one variation, an exhaust collection bag may be supported by a poleand connected to the exhaust line for collecting the exhaust fluids orgases. The evacuating exhaust line may be removably coupled to thecollection bag via a tubing connector located near or at a bottom of thecollection bag. The bag itself may be formed from two layers of alubricious materials which are attached or welded (e.g., RF dielectricwelded) around its periphery along its edges. Moreover, the collectionbag may be configured to form an extension which projects from the bagand forms an opening for passing a hook through or to provide a pointfor attachment. The collection bag may be designed to hang, e.g., froman IV pole as shown such that it is maintained off the floor to keep itclean should a user want to reuse it a number of times.

The bag may be fabricated from, e.g., a polyurethane film, selected forits lubricity, elasticity, clarity, low cost and ability to be RFdielectric welded. The film may have a thickness of, e.g., 0.003 inches.Because the bag inflates at relatively low pressures, the lubricity ofthe layers prevents the layers of film from sticking together and allowsthe bag to readily inflate. Also, to accommodate potential volumeincreases associated with increased temperatures, the bag material alsoexhibits elasticity, e.g., film elongation may be on the order of 800%.The bag may be fabricated to have a burst pressure of at least greaterthan or equal to, e.g., ≥3 psi. The bag may also be fabricated so as tobe at least partially transparent so that the clarity of the bag resultsin an object that visually occupies less space in the procedure roombecause objects can be seen through it.

The tubing connector may further incorporate one or more variations of asupport member which may function as a tenting structure to prevent thelayers of the bag from collapsing upon itself and trapping any exhaustgases. Additionally and/or optionally, the bag itself may incorporatefeatures which enable the bag to collapse upon itself to force exhaustgases out of the bag interior.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side view of an integrated treatment assembly.

FIG. 1B shows an example of the assembly advanced through the cervix andinto the uterus where the sheath may be retracted via the handleassembly to deploy the balloon.

FIG. 1C shows a perspective view of a cryoablation assembly having ahandle assembly which may integrate the electronics and pump assemblywithin the handle itself.

FIG. 1D shows the handle assembly in a perspective exploded viewillustrating some of the components which may be integrated within thehandle.

FIG. 1E shows an example of the system operation during a pre-treatmentpuff up process.

FIG. 1F shows an example of the system operation during a treatmentprocess.

FIG. 1G shows an example of the system operation during a thawing andventing process.

FIGS. 2A and 2B show cross-sectional side views of yet another variationof a cooling probe which utilizes a single infusion line in combinationwith a translatable delivery line.

FIGS. 3A and 3B show top and perspective views of the expanded linerwith four pairs of the open delivery ports exposed in apposed direction.

FIGS. 4A to 4C show side and assembly views of another variation of thetreatment assembly.

FIGS. 5A and 5B show examples of collection systems which can be used tocollect the discharged liquid or gas.

FIG. 6 shows another example of collection system utilizing a bag forcollecting the discharged liquid or gas.

FIGS. 7A and 7B show respective front and detail views of the collectionbag in a flattened configuration.

FIGS. 8A and 8B show front and side views of the collection bag in anexpanded configuration.

FIG. 9 shows a side view of a support member having a gentle dome-shapedor curved structure defining one or more openings along its surface.

FIGS. 10A and 10B show perspective and side views of another variationof the support member which has a dome-shaped feature formed in ahemi-spherical shape.

FIGS. 11A and 11B show perspective and side views of another variationof the support member having a curved interface member which extendsbeyond a periphery of the support member where the one or more openingsare defined.

FIGS. 12A and 12B show perspective and side views of yet anothervariation where the support member has a curved surface but also definesan opening or lumen extending through the member.

FIGS. 13A and 13B show perspective and side views of yet anothervariation where the support member may be formed of a peripheral memberhaving one or more extensions formed around a periphery of the memberand projecting away from the support member.

FIGS. 14A and 14B show side views of yet another support member formedas a helical member or spring forming a channel and extending away fromthe tubing connector.

FIGS. 15A and 15B show cross-sectional side views of yet anothervariation of a support member which is formed as a flexible convolutedor perforated tube having a helically-shaped projection formed along theouter surface of the tube.

FIGS. 16A and 16B show perspective and side views of yet anothervariation of a support member having first set of projections and asecond set of projections over the surface of the support member.

FIGS. 17A and 17B show perspective and side views of yet anothervariation in which the support member may have one or more projectionswith atraumatic ends forming a clearance channel between each of theprojections.

FIGS. 18A to 18C show detail side views of yet another variation of aninternal support mechanism configured to maintain the bag in an expandedconfiguration to prevent the layers from collapsing upon one another.

FIGS. 19A to 19C show top views of the bag correlating to FIGS. 18A to18C.

FIGS. 20A to 20C show side views of a bag incorporating a self-coilingsupport member which may extend along the length of the bag.

DETAILED DESCRIPTION OF THE INVENTION

The cooling probe 22 as well as the balloon assembly may be variouslyconfigured, for instance, in an integrated treatment assembly 10 asshown in the side view of FIG. 1A. In this variation, the assembly 10may integrate the elongate shaft 18 having the liner or balloon 20extending therefrom with the cooling probe 22 positioned translatablywithin the shaft 18 and liner 20. A separate translatable sheath 12 maybe positioned over the elongate shaft 18 and both the elongate shaft 18and sheath 12 may be attached to a handle assembly 14. The handleassembly 14 may further comprise an actuator 16 for controlling atranslation of the sheath 12 for liner 20 delivery and deployment.

With the sheath 12 positioned over the elongate shaft 18 and liner 20,the assembly 10 may be advanced through the cervix and into the uterusUT where the sheath 12 may be retracted via the handle assembly 14 todeploy the liner 20, as shown in FIG. 1B. As described above, once theliner 20 is initially deployed from the sheath 12, it may be expanded byan initial burst of a gas, e.g., air, carbon dioxide, etc., or by thecryoablative fluid. In particular, the tapered portions of the liner 20may be expanded to ensure contact with the uterine cornu. The handleassembly 14 may also be used to actuate and control a longitudinalposition of the cooling probe 22 relative to the elongate shaft 18 andliner 20 as indicated by the arrows.

In another variation of the treatment assembly, FIG. 1C shows aperspective view of a cryoablation assembly having a handle assembly 24which may integrate the electronics and pump assembly 28 within thehandle itself. An exhaust tube 26 may also be seen attached to thehandle assembly 24 for evacuating exhausted or excess cryoablative fluidor gas from the liner 20. Any of the cryoablative fluids or gasesdescribed herein may be utilized, e.g., compressed liquid-to-gas phasechange of a compressed gas such as nitrous oxide (N₂O), carbon dioxide(CO₂), Argon, etc. The cooling probe 22 may be seen extending fromsheath 12 while surrounded or enclosed by the liner or balloon 20.Hence, the handle assembly 24 with coupled cooling probe 22 and liner 20may provide for a single device which may provide for pre-treatmentpuff-up or inflation of the liner 20, active cryoablation treatment,and/or post-treatment thaw cycles.

The handle assembly 24 may also optionally incorporate a display forproviding any number of indicators and/or alerts to the user. Forinstance, an LCD display may be provided on the handle assembly 24 (orto a separate control unit connected to the handle assembly 24) wherethe display counts down the treatment time in seconds as the ablation isoccurring. The display may also be used to provide measured pressure ortemperature readings as well as any number of other indicators, symbols,or text, etc., for alerts, instructions, or other indications. Moreover,the display may be configured to have multiple color-coded outputs,e.g., green, yellow, and red. When the assembly is working through theideal use case, the LED may be displayed as a solid green color. Whenthe device requires user input (e.g. when paused and needing the user topress the button to re-start treatment) the LED may flash or displayyellow. Additionally, when the device has faulted and treatment isstopped, the LED may flash or display a solid red color.

FIG. 1D shows the handle assembly 24 in a perspective exploded view toillustrate some of the components which may be integrated within thehandle 24. As shown, the liner 20 and sheath 12 may be coupled to asheath bearing assembly 32 and slider base block assembly 34 forcontrolling the amount of exposed treatment length along the coolingprobe 22 (and as described in further detail below). An actuatablesheath control 36 may be attached to the slider base block assembly 34for manually controlling the treatment length of the cooling probe 22 aswell. Along with the electronics and pump assembly 28 (which mayoptionally incorporate a programmable processor or controller inelectrical communication with any of the mechanisms within the handle24), an exhaust valve 30 (e.g., actuated via a solenoid) may be coupledto the exhaust line 26 for controlling not only the outflow of theexhausted cryoablation fluid or gas but also for creating or increasinga backpressure during treatment, as described in further detail below.

In one example of how the handle assembly 24 may provide for treatment,FIGS. 1E to 1G illustrate schematic side views of how the components maybe integrated and utilized with one another. As described herein, oncethe sheath 12 and/or liner 20 has been advanced and initially introducedinto the uterus, the liner 20 may be expanded or inflated in apre-treatment puff up to expand the liner 20 into contact against theuterine tissue surfaces in preparation for a cryoablation treatment. Asillustrated in the side view of FIG. 1E, a pump 38 integrated within thehandle assembly 24 may be actuated and a valve 42 (e.g., actuatable orpassive) fluidly coupled to the pump 38 may be opened (as indicatedschematically by an “O” over both the pump 38 and valve 42) such thatambient air may be drawn in through, e.g., an air filter 40 integratedalong the handle 24, and passed through an air line 44 within the handleand to an exhaust block 46. The exhaust block 46 and air line 44 may befluidly coupled to the tubular exhaust channel which extends from thehandle 24 which is further attached to the cooling probe 22. As the airis introduced into the interior of the liner 20 (indicated by thearrows), the liner 20 may be expanded into contact against thesurrounding uterine tissue surface.

A cryoablative fluid line 48 also extending into and integrated withinthe handle assembly 24 may be fluidly coupled to an actuatable valve 50,e.g., actuated via a solenoid, which may be manually closed orautomatically closed (as indicated schematically by an “X” over thevalve 50) by a controller to prevent the introduction of thecryoablative fluid or gas into the liner 20 during the pre-treatmentliner expansion. An infusion line 52 may be fluidly coupled to the valve50 and may also be coupled along the length of the sheath 12 and probe22, as described in further detail below. The exhaust valve 30 coupledto the exhaust line 26 may also be closed (as indicated schematically byan “X” over the valve 30) manually or automatically by the controller toprevent the escape of the air from the exhaust block 46.

During this initial liner expansion, the liner 20 may be expanded in agradual and controlled manner to minimize any pain which may beexperienced by the patient in opening the uterine cavity. Hence, theliner 20 may be expanded gradually by metering in small amounts of air.Optionally, the pump 38 may be programmed and controlled by a processoror microcontroller to expand the liner 20 according to an algorithm(e.g., e.g. ramp-up pressure quickly to 10 mm Hg and then slow-down theramp-up as the pressure increases to 85 mm Hg) which may be stopped orpaused by the user. Moreover, the liner 20 may be expanded to a volumewhich is just sufficient to take up space within the uterine cavity.After the initial increase in pressure, the pressure within the liner 20may be optionally increased in bursts or pulses. Moreover, visualization(e.g., via a hysteroscope or abdominal ultrasound) may be optionallyused during the controlled gradual expansion to determine when theuterine cavity is fully open and requires no further pressurization. Inyet another variation, the liner 20 may be cyclically inflated anddeflated to fully expand the liner. The inflations and deflations may bepartial or full depending upon the desired expansion.

In yet another alternative variation, the system could also use anamount of air pumped into the liner 20 as a mechanism for detectingwhether the device is in a false passage of the body rather than theuterine cavity to be treated. The system could use the amount of timethat the pump 38 is on to track how much air has been pushed into theliner 20. If the pump 38 fails to reach certain pressure levels within apredetermined period of time, then the controller may indicate that thedevice is positioned within a false passage. There could also be a limitto the amount of air allowed to be pushed into the liner 20 as a way todetect whether the probe 22 has been pushed, e.g., out into theperitoneal cavity. If too much air is pushed into the liner 20 (e.g.,the volume of air tracked by the controller exceeds a predeterminedlevel) before reaching certain pressures, then the controller mayindicate the presence of a leak or that the liner 20 is not fullyconstrained by the uterine cavity. The liner 20 may also incorporate arelease feature which is configured to rupture if the liner 20 is notconstrained such that if the system attempts to pump up the liner 20 totreatment pressure (e.g., 140 mmHg), the release feature will rupturebefore reaching that pressure.

Once the liner 20 has been expanded sufficiently into contact againstthe uterine tissue surface, the cryoablation treatment may be initiated.As shown in the side view of FIG. 1F, the air pump 38 may be turned offand the valve 42 may be closed (as indicated schematically by an “X”over the pump 38 and valve 42) to prevent any further infusion of airinto the liner 20. With the cryoablative fluid or gas pressurized withinthe line 48, valve 50 may be opened (as indicated schematically by an“O” over the valve 50) to allow for the flow of the cryoablative fluidor gas to flow through the infusion line 52 coupled to the valve 50.Infusion line 52 may be routed through or along the sheath 12 and alongthe probe 22 where it may introduce the cryoablative fluid or gas withinthe interior of liner 20 for infusion against the liner 20 contactedagainst the surrounding tissue surface.

During treatment or afterwards, the exhaust valve 30 may also be opened(as indicated schematically by an “O” over the valve 30) to allow forthe discharged fluid or gas to exit or be drawn from the liner interiorand proximally through the cooling probe 22, such as through the distaltip opening. The fluid or gas may exit from the liner 20 due to apressure differential between the liner interior and the exhaust exitand/or the fluid or gas may be actively drawn out from the linerinterior, as described in further detail herein. The spent fluid or gasmay then be withdrawn proximally through the probe 22 and through thelumen surrounded by the sheath 12, exhaust block 46, and the exhausttube 26 where the spent fluid or gas may be vented. With the treatmentfluid or gas thus introduced through infusion line 52 within the liner20 and then withdrawn, the cryoablative treatment may be applieduninterrupted.

Once a treatment has been completed, the tissue of the uterine cavitymay be permitted to thaw. During this process, the cryoablative fluiddelivery is halted through the infusion line 52 by closing the valve 50(as indicated schematically by an “X” over the valve 50) whilecontinuing to exhaust for any remaining cryoablative fluid or gasremaining within the liner 20 through probe 22, through the lumensurrounded by sheath 12, and exhaust line 26, as shown in FIG. 1G.Optionally, the pump 38 and valve 42 may be cycled on and off and theexhaust valve 30 may also be cycled on and off to push ambient air intothe liner 20 to facilitate the thawing of the liner 20 to the uterinecavity. Optionally, warmed or room temperature air or fluid (e.g.,saline) may also be pumped into the liner 20 to further facilitatethawing of the tissue region.

As the spent cryoablative fluid or gas is removed from the liner 20, adrip prevention system may be optionally incorporated into the handle.For instance, a passive system incorporating a vented trap may beintegrated into the handle which allows exhaust gas to escape butcaptures any vented liquid. The exhaust line 26 may be elongated toallow for any vented liquid to evaporate or the exhaust line 26 may beconvoluted to increase the surface area of the exhaust gas tube topromote evaporation.

Alternatively, an active system may be integrated into the handle orcoupled to the handle 24 where a heat sink may be connected to atemperature sensor and electrical circuit which is controlled by aprocessor or microcontroller. The heat sink may promote heat transferand causes any liquid exhaust to evaporate. When the temperature of theheat sink reaches the boiling temperature of, e.g., nitrous oxide(around −86° C.), the handle may be configured to slow or stop thedelivery of the cryoablative fluid or gas to the uterine cavity.

The pre-treatment infusion of air as well as the methods for treatmentand thawing may be utilized with any of the liner, probe, or apparatusvariations described herein. Moreover, the pre-treatment, treatment, orpost-treatment procedures may be utilized altogether in a singleprocedure or different aspects of such procedures may be used in varyingcombinations depending upon the desired results.

Additionally and/or optionally, the handle 24 may incorporate anorientation sensor to facilitate maintaining the handle 24 in adesirable orientation for treatment. One variation may incorporate aball having a specific weight covering the exhaust line 26 such thatwhen the handle 24 is held in the desirable upright orientation, thetreatment may proceed uninterrupted. However, if the handle 24 moved outof its desired orientation, the ball may be configured to roll out ofposition and trigger a visual and/or auditory alarm to alert the user.In another variation, an electronic gyroscopic sensor may be used tomaintain the handle 24 in the desired orientation for treatment.

FIGS. 2A and 2B show cross-sectional side views of yet another variationof a cooling probe which utilizes a single infusion line in combinationwith a translatable delivery line. To accommodate various sizes andshapes of uterine cavities, the cooling probe may have a slidingadjustment that may be set, e.g., according to the measured length ofthe patient's uterine cavity. The adjustment may move along the sheathalong the exhaust tube as well as the delivery line within the infusionline. The sheath may constrain the liner 20 and also control itsdeployment within the cavity.

In this variation, an infusion line 52 (as described above) may passfrom the handle assembly and along or within the sheath and into theinterior of liner 20. The infusion line 52 may be aligned along theprobe 22 such that the infusion line 52 is parallel with a longitudinalaxis of the probe 22 and extends towards the distal tip 66 of the probe22. Moreover, the infusion line 52 may be positioned along the probe 22such that the line 52 remains exposed to the corners of the liner 20which extend towards the cornua. With the infusion line 52 positionedaccordingly, the length of the line 52 within the liner 20 may havemultiple openings formed along its length which act as delivery portsfor the infused cryoablative fluid or gas. A separate translatingdelivery line 64, e.g., formed of a Nitinol tube defining an infusionlumen therethrough, may be slidably positioned through the length of theinfusion line 52 such that the delivery line 64 may be moved (asindicated by the arrows in FIG. 2A) relative to the infusion line 52which remains stationary relative to the probe 22.

The openings along the length of the infusion line 52 may be positionedsuch that the openings are exposed to the sides of the interior of theliner 20, e.g., cross-drilled. As the cryoablative fluid or gas isintroduced through the delivery line 64, the infused cryoablative fluidor gas 68 may pass through the infusion line 52 and then out through theopenings defined along the infusion line 52. By adjusting thetranslational position of the delivery line 64, the delivery line 64 mayalso cover a selected number of the openings resulting in a number ofopen delivery ports 60 as well as closed delivery ports 62 which areobstructed by the delivery line 64 position relative to the infusionline 52, as shown in the top view of FIG. 2B.

By translating the delivery line 64 accordingly, the number of opendelivery ports 60 and closed delivery ports 62 may be adjusted dependingon the desired treatment length and further ensures that only desiredregions of the uterine tissue are exposed to the infused cryoablativefluid or gas 68. Once the number of open delivery ports 60 has beensuitably selected, the infused cryoablative fluid or gas 68 may bypassthe closed delivery ports 62 obstructed by the delivery line 64 and thefluid or gas may then be forced out through the open delivery ports 60in a transverse direction as indicated by the infusion spray direction70. The terminal end of the infusion line 52 may be obstructed toprevent the distal release of the infused fluid or gas 68 from itsdistal end. Although in other variations, the terminal end of theinfusion line 52 may be left unobstructed and opened.

FIGS. 3A and 3B show top and perspective views of the expanded liner 20with four pairs of the open delivery ports 60 exposed in apposeddirection. Because the infused fluid or gas 68 may be injected into theliner 20, e.g., as a liquid, under relatively high pressure, theinjected cryoablative liquid may be sprayed through the open deliveryports 60 in a transverse or perpendicular direction relative to thecooling probe 22. The laterally infused cryoablative fluid 70 may sprayagainst the interior of the liner 20 (which is contacted against thesurrounding tissue surface) such that the cryoablative liquid 70 coatsthe interior walls of the liner 20 due to turbulent flow causing heavymixing. As the cryoablative liquid 70 coats the liner surface, thesprayed liquid 70 may absorb heat from the tissue walls causing rapidcooling of the tissue while also evaporating the liquid cryogen to a gasform that flows out through the cooling probe 22. This rapid cooling andevaporation of the cryoablative liquid 70 facilitates the creation of afast and deep ablation over the tissue. During treatment, thetemperature within the cavity typically drops, e.g., −86° C., within 2-3seconds after the procedure has started. While the interior walls of theliner 20 are first coated with the cryoablative liquid 70, a portion ofthe cryoablative liquid 70 may no longer change phase as the procedureprogresses.

While four pairs of the open delivery ports 60 are shown, the number ofexposed openings may be adjusted to fewer than four pairs or more thanfour pairs depending on the positioning of the delivery line 64 and alsothe number of openings defined along the infusion line 52 as well as thespacing between the openings. Moreover, the positioning of the openingsmay also be adjusted such that the sprayed liquid 70 may spray inalternative directions rather than laterally as shown. Additionallyand/or alternatively, additional openings may be defined along otherregions of the infusion line 52.

Further variations of the treatment assembly features and methods whichmay be utilized in combination with any of the features and methodsdescribed herein may be found in the following patent applications:

U.S. patent application Ser. No. 13/361,779 filed Jan. 30, 2012 (US Pub.2012/0197245);

U.S. patent application Ser. No. 13/900,916 filed May 23, 2013 (US Pub.2013/0296837);

U.S. patent application Ser. No. 14/019,898 filed Sep. 6, 2013 (US Pub.2014/0012156);

U.S. patent application Ser. No. 14/019,928 filed Sep. 6, 2013 (US Pub.2014/005648);

U.S. patent application Ser. No. 14/020,265 filed Sep. 6, 2013 (US Pub.2014/0005649);

U.S. patent application Ser. No. 14/020,306 filed Sep. 6, 2013 (US Pub.2014/0025055);

U.S. patent application Ser. No. 14/020,350 filed Sep. 6, 2013 (US Pub.2014/0012244);

U.S. patent application Ser. No. 14/020,397 filed Sep. 6, 2013 (US Pub.2014/0012243);

U.S. patent application Ser. No. 14/020,452 filed Sep. 6, 2013 (US Pub.2014/0005650);

U.S. patent application Ser. No. 14/086,050 filed Nov. 21, 2013 (US Pub.2014/0074081);

U.S. patent application Ser. No. 14/086,088 filed Nov. 21, 2013 (US Pub.2014/0088579);

U.S. patent application Ser. No. 14/029,641 filed Sep. 17, 2013 (US Pub.2015/0080869); and

U.S. patent application Ser. No. 14/265,799 filed Apr. 30, 2014 (US Pub.2015/0289920).

Each of the patent applications above is incorporated herein byreference in its entirety and for any purpose herein.

Yet another variation of the treatment assembly 80 is shown in the sideand partial cross-sectional side views of FIGS. 4A and 4B whichillustrate a housing 82 having a handle 84 and a reservoir housing 88extending from and attached directly to the handle 84. FIG. 4C furtherillustrates a perspective assembly view of the treatment assembly 80 andsome of its components contained internally.

The sheath 12 having the liner 20 may extend from the housing 82 whilean actuator 86 may be located, for instance, along the handle 84 toenable the operator to initiate the cryoablative treatment. A reservoiror canister 92 fully containing the cryoablative agent (as describedherein) may be inserted and retained within the reservoir housing 88.The reservoir housing 88 and/or the handle 84 may further incorporate areservoir engagement control 90 which may be actuated, e.g., by rotatingthe control 90 relative to the handle 84, to initially open fluidcommunication with the reservoir or canister 92 to charge the system fortreatment.

The reservoir or canister 92 may be inserted into the reservoir housing88 and into secure engagement with a reservoir or canister valve 94which may be coupled to the reservoir engagement control 90. The valve94 may be adjusted to open the reservoir or canister 92 for treatment orfor venting of the discharged cryoablative agent during or aftertreatment. An inflow modulation control unit 96 (e.g., an actuatablesolenoid mechanism) may be coupled directly to the reservoir or canistervalve 94 and the cryoablative fluid line 48 may be coupled directly tothe modulation control unit 96 and through the sheath 12 and into fluidcommunication within the liner 20, as described herein.

During or after treatment, the discharged cryoablative fluid may beevacuated through the exhaust block 46 contained within the housing andthen through the exhaust line 98 coupled to the exhaust block 46. Theexhaust line 98 may extend through the handle 84 and the reservoirhousing 88 and terminate at an exhaust line opening 100 which may beattached to another exhaust collection line.

With the discharged cryoablative agent in a completely gaseous state,the evacuating exhaust line 140 may be vented to the surroundingenvironment or optionally coupled to a scavenging system to collect thedischarged gas to limit exposure. FIGS. 5A and 5B show assembly views ofexamples of collection bags which may be optionally used with thetreatment assembly. Scavenging systems may incorporate features such asorifices or valves to prevent any vacuum applied by the scavenging unitfrom interfering with the backpressure within the treatment device.

FIG. 5A shows an inflating collection bag 150 which is expandable inwidth coupled to the evacuating exhaust line 140 via a disconnect valve152 (e.g., unidirectional valve). The collection bag 150, which may bereusable or disposable, may be supported via a pole 156 and may alsoincorporate a release plug 154 which may allow for the venting of thecollected gas during or after a treatment procedure is completed.

Similarly, FIG. 5B shows an accordion-type collector 160 also supportedvia a pole 156 and a connector 166 attached to the collector 160. Theevacuating exhaust line 140 may be removably coupled to the collector160 via a disconnect valve 162 (e.g., unidirectional valve) and may alsoincorporate a release plug 164 for venting any collected gas during orafter a treatment procedure. The vertically-expanding collector 160 maydefine a hollow passageway through the center of the vertical bellowswhich allows for the connector 166 (e.g., rigid rod or flexible cord) topass through and support the base of the collector 160. The connector166 also prevents the collector 160 from falling over to a side wheninflating. As the gas enters through the bottom of the collector 160,the bellow may inflate upward.

In yet another variation, FIG. 6 shows an exhaust collection bag 170which may also be supported by the pole 156. The evacuating exhaust line140 may be removably coupled to the collection bag 170 via a tubingconnector 172 located near or at a bottom of the collection bag 170. Thebag 170 itself may be formed from two layers of a lubricious materialswhich are attached or welded (e.g., RF dielectric welded) around itsperiphery along its edges 178. Moreover, the collection bag 170 may beconfigured to form an extension 174 which projects from the bag 170 andforms an opening 176 for passing a hook through or to provide a pointfor attachment. This opening may be reinforced to support, e.g., 2 lbsfor at least 1 hour. The collection bag 170 may be designed to hang,e.g., from an IV pole as shown such that it is maintained off the floorto keep it clean should a user want to reuse it a number of times.

The bag 170 may be fabricated from, e.g., a polyurethane film, selectedfor its lubricity, elasticity, clarity, low cost and ability to be RFdielectric welded. Such polyurethane films may be commercially availablefrom API Corporation (DT 2001-FM). The film may have a thickness of,e.g., 0.003 inches. Because the bag 170 inflates at relatively lowpressures, the lubricity of the layers prevents the layers of film fromsticking together and allows the bag to readily inflate. Also, toaccommodate potential volume increases associated with increasedtemperatures, the bag 170 material also exhibits elasticity, e.g., filmelongation may be on the order of 800%. The bag may be fabricated tohave a burst pressure of at least greater than or equal to, e.g., ≥3psi. The bag 170 may also be fabricated so as to be at least partiallytransparent so that the clarity of the bag results in an object thatvisually occupies less space in the procedure room because objects canbe seen through it.

FIG. 7A shows a collection bag 170 when flattened (e.g., when deflatedprior to use) for illustrative purposes and FIG. 7B shows a detail viewof the extension 174. As shown, bag 170 may be formed to include tubingconnector 172 which may be positioned near or at a bottom of the bag 170when hanging during use. The bag 170 may be formed with rounded orcurved corners having a radius R1, e.g., 11.0 inches, around all four ofits corners so as to facilitate exhaust gas infusion and removal fromthe bag interior volume.

When flattened, the bag 170 may measure in one variation, e.g., 25inches in width and 45.5 inches in length. The tubing connector 172 maybe located along a centerline CL of the bag 170 which may alsoincorporate a drain closure 180 which may be opened to facilitate theremoval of any collected exhaust gases within the bag 170 after theconclusion of a treatment procedure. The tubing connector 172 may belocated, e.g., 7.0 inches from the bottom of the bag 170, while thedrain closure 180 may be located, e.g., 3.1 inches from the bottom and3.0 inches from the centerline CL. While the connector 172 and drainclosure 180 are located on the same side of the bag 170, they may alsobe located on opposite sides or along the sides of the bag 170, if sodesired. Moreover, the tubing connector 172 may incorporate a valve andalso be configured as a quick disconnect fitting which allows the userto connect the exhaust line 140 during a procedure to collect theexhaust gas and to also prevent the outflow of gas when disconnectedfrom the bag 170 at the end of the treatment.

Additionally and/or optionally, the collection bag 170 may be configuredwith two vent ports to enable it to be vented either manually or viawall suction. To facilitate wall suction, an extra quick disconnectadapter may be provided and stored in pouch 182 at the top of the bag170. The user may simply push the quick disconnect onto the suctiontubing (connected on the other end to wall suction) and then connect thequick disconnect fitting into the tubing connector 172 on the collectionbag. The manual vent port may simply comprise the drain closure 180 thatcan be pulled-out by the user. The drain closure 180 may be positionednear or at the bottom of the bag 170 to reduce the user's exposure toN₂O while emptying the bag 170. Locating the drain closure 180 at thebottom of the bag 170 also enables the user to roll the bag from topdown to empty it.

The extension 176, shown in the detail view of FIG. 7B, may be formedwith an optional pouch 182 and may also form a radius R2, e.g., 1.0inches, between the bag 170 and extension 176 and a radius R3, e.g., 1.5inches, around the extension 176 itself.

FIGS. 8A and 8B show respective front and side views of the bag 170 inits inflated state. When filled with the exhaust gas, bag 170 may expandsuch its width and length reduces, e.g., 21.0 inches in width and 41.5inches in length. Moreover, the layers of material forming the bag 170may also separate from one another forming a height of thickness of,e.g., 10.0 inches, when fully expanded.

Making the bag 170 over-sized lengthwise further allows the volume to bedistributed in such a way that it is less intrusive in the procedureroom. A shorter, wider collection bag occupies more space where peopleand other equipment are often located. The size and shape of the bag 170make it easier to manually transport and, if necessary, to open and ventthe bag 170 outside.

Aside from the bag 170 itself, the tubing connector 172 may alsoincorporate a number of features to facilitate emptying of the bag 170.As the bag 170 is evacuated via an external suction source, a first side192A of the bag 170, e.g., the layer of the bag 170 where the tubingconnector 172 is positioned, and a second side 192B of the bag 170,e.g., the layer of the bag 170 opposite to the first side 192A, maycollapse upon itself and adhere to one another particularly around thearea of the bag where the tubing connector 172 is positioned therebytrapping exhaust gas in the remainder of the bag 170 and preventing itfrom evacuating.

One example of an apparatus for facilitating evacuation is shown in theside view of FIG. 9 which illustrates assembly 190. The tubing connector172 may incorporate a support member 194 having a contact surface whichhas a gentle dome-shaped or curved structure defining one or moreopenings 196 along its surface, e.g., around a periphery of the member194. The member 194 may extend from the tubing connector 172 and intothe interior of the bag 170. The interior of the member 194 may allowfor fluid communication through the openings 196 and a channel 200defined through the member 194. In use, as the layers 192A, 192Bcollapse, the member 194 may function as a tenting structure whichprevents the layers 192A, 192B from fully adhering to one another andthereby maintaining formed channels 198 around the member 194. Thesechannels 198 allow for the trapped gas to pass through the openings 196,into the channel 200, and out the tubing connector 172. The supportmember 194 may be fabricated from any number of structurally robustmaterials, e.g., plastics, polymers, metals, etc.

This support member or any of the support members described herein maybe used in any number of combinations with any of the other featuresdescribed herein.

FIG. 10A shows a perspective view of another variation of the supportmember 210 which has a dome-shaped feature 212 formed in ahemi-spherical shape. The one or more openings 214 may be formed arounda periphery of the member 210 with the channel 216 fluidly incommunication through the member 210. FIG. 10B shows a side view of thesupport member 210 attached to the tubing connector 172 within the baginterior and the formed channels 198 around the periphery of the member210.

FIG. 11A shows a perspective view of another variation of the supportmember 220 having a curved interface member 222 which extends beyond aperiphery of the support member 220 where the one or more openings 224are defined. FIG. 11B shows a side view of the support member 220 andillustrates how the curved interface member 222 maintains the formedchannel 198 for evacuating the gas through the openings 224 and throughthe channel 226.

FIG. 12A shows a perspective view of yet another variation where thesupport member 230 has a curved surface 232 but also defines an openingor lumen 234 extending through the member 230. The side view of FIG. 12Billustrates how the opening or lumen 234 may help to pull the secondlayer 192B into the opening to help pull and/or retain the layermaterial to maintain the openings 236 unobstructed for evacuating theexhaust gas through the openings 236 and channel 238.

FIG. 13A shows a perspective view of yet another variation where thesupport member 240 may be formed of a peripheral member having one ormore extensions 242 formed around a periphery of the member andprojecting away from the support member 240 to form one or morecorresponding channels 244 between the extensions 242. The side view ofFIG. 13B shows the support member 240 attached to the tubing connector172 such that the one or more extensions 242 extend away from the member240 and into the interior of the bag. The one or more extensions 242functions to tent the material of the bag such that the exhaust gas mayexit through the channels 244 and out through the channel 246.

FIG. 14A shows a side view of yet another support member 250 formed as ahelical member or spring forming a channel 254 and extending away fromthe tubing connector 172. The distal tip 252 of the member 250 may beformed to be atraumatic so that as the layer 192B collapses onto themember 250, the distal tip 252 is inhibited from piercing through thebag 170, as shown in the side view of FIG. 14B. The channel 254 mayremain clear of the layer material thereby allowing the exhaust gas fromexiting through the channel 254 and out the tubing connector 172.

FIG. 15A shows a cross-sectional side view of yet another variation of asupport member 260 which is formed as a flexible convoluted orperforated tube 262 having a helically-shaped projection 264 formedalong the outer surface of the tube 262. The tube 262 may also defineone or more openings 266 through the surface of the tube 262 so that theopenings 266 extend into the channel 268 formed through the length ofthe tube 262. FIG. 15B shows how the projection 264 may prevent thelayer material 192B from sealing around the outer surface of the tube262 so that the exhaust gas may flow into and through the openings 266,through the channel 268, and out through tubing 172. The flexibility ofthe tube 262 may also allow for the support member 260 to bend and flexfurther allowing for tenting of the bag material and the maintenance ofthe channels 198 around the support member 260.

FIG. 16A shows a perspective view of yet another variation of a supportmember 270 having first set of projections 272 formed to extend parallelto one another in a first direction over the surface of the supportmember 270 and a second set of projections 274 formed to extend parallelto one another in a second direction over the surface of the supportmember 270 and extending at an angle (or transverse) relative to thefirst set of projections 272. The resulting construct may form a waffledor uneven surface to help maintain clearance of the layer 192B. One ormore openings 276 may be defined through the support member in fluidcommunication with the channel 278. FIG. 16B shows a side viewillustrating how the support member 270 may maintain clearance of theopenings 276 due to the uneven surface presented to the layer 192B tohelp clear the exhaust gas.

FIG. 17A shows a perspective view of yet another variation in which thesupport member 280 may have one or more projections 282 with atraumaticends forming a clearance channel 284 between each of the projections282. FIG. 17B shows a side view illustrating how the projections 282 maytent the layer 192B to maintain the clearance channel 284 to allow forthe exhaust gas to flow through the channel 286 and out of the tubing172. The number of projections 282 and spacing between may be varieddepending upon the amount of clearance to be maintained.

FIGS. 18A to 18C show detail side views of yet another variation of aninternal support mechanism configured to maintain the bag 170 in anexpanded configuration to prevent the layers 192A, 192B from collapsingupon one another. The support mechanism may be comprised in thisvariation of a first member 290A and apposed second member 290Bconnected to one another via a hinged, pivoting, or otherwisecollapsible connector 292. An additional scaffold member formed of afirst scaffold 294A and apposed second scaffold 294B connected toanother via connector 296 may extend between the first and secondmembers 290A, 290B. Once the bag 170 has been evacuated, the expandedbag may be collapsed, e.g., for storage or disposal, by urging the firstand second members 290A, 290B towards one another via connector 292, asshown in FIGS. 18B and 18C. The first and second scaffold 294A, 294B areomitted from the figures for clarity but are shown in the top views ofFIGS. 19A to 19C which correlate to the collapse of FIGS. 18A to 18C.Similarly, the first and second scaffold 294A, 294B may be collapsedtowards one another via the hinge or pivot 296 so that the bag may bereconfigured from its expanded configuration into its fully (orpartially) collapsed configuration, as shown.

In yet another variation, FIGS. 20A to 20C show side views of a bag 170incorporating a self-coiling support member 300 which may extend alongthe length of the bag 170. The support member 300 may form a structuralspine formed integrally along, e.g., second layer 192B of the bag 170,or attached separately to either the bag interior or exterior or betweenlayers of the bag 170 (if formed via multiple layers). The supportmember 300 may be formed of a coiling structure (e.g., plastics, metals,alloys, etc.) which imparts a collapsing force upon the bag 170. Wheninflated with the exhaust gas, as shown in FIG. 20A, the bag 170 maymaintain is expanded configuration but as the gas is removed from thebag, a first portion 302 of the support member 300 may begin to collapseby coiling. As the first portion 302 of member 300 begins to coil, thefirst (or upper) portion 304 of the bag 170 may be urged to collapsefurther forcing any exhaust gas into the second (or lower) portion 306of the bag 170, as shown in FIG. 20B. As additional exhaust gas isremoved from the bag 170, the first portion 302 of support member 300may fully coil or collapse thereby accelerating the venting of the gasalso from the second portion 304 of the bag 170, as shown in FIG. 20C.

This collapsing support member described herein may be used in anynumber of combinations with any of the other support members describedor with any of the other features described herein.

While illustrative examples are described above, it will be apparent toone skilled in the art that various changes and modifications may bemade therein. Moreover, various apparatus or procedures described aboveare also intended to be utilized in combination with one another, aspracticable. The appended claims are intended to cover all such changesand modifications that fall within the true spirit and scope of theinvention.

What is claimed is:
 1. A method of disposing an exhaust gas, comprising:fluidly coupling a tubing from a cryoablation instrument to a collectionbag such that an exhaust gas is received from the cryoablationinstrument and into the collection bag over a course of a cryoablativetreatment upon a subject; decoupling the tube from a tubing connectorattached to the collection bag; and collapsing the collection bag from aproximal end to a distal end such that the collection bag collapseswhile venting the exhaust gas through a drain closure located inproximity to the distal end of the collection bag.
 2. The method ofclaim 1 wherein the cryoablative treatment comprises cryoablating auterine lining of the subject.
 3. The method of claim 1 wherein fluidlycoupling the tubing comprises coupling the tubing to the tubingconnector located along a midline of the collection bag.
 4. The methodof claim 1 wherein fluidly coupling the tubing further comprisessuspending the collection bag from the proximal end.
 5. The method ofclaim 1 wherein the collection bag comprises a first layer and a secondlayer attached along a periphery and forming an enclosed volume, whereinthe drain closure is positioned along the first layer and extendsthrough the first layer in fluid communication with the enclosed volume.6. The method of claim 1 wherein the collection bag is expandable by upto 800%.
 7. The method of claim 1 wherein the collection bag has a burstpressure of at least greater than or equal to 3 psi.
 8. The method ofclaim 1 wherein decoupling the tube further comprises relocating thecollection bag remotely from the subject.
 9. The method of claim 1wherein collapsing the collection bag comprises rolling the collectionbag from the proximal end to the distal end.
 10. The method of claim 1wherein collapsing the collection bag comprises suctioning the exhaustgas through the drain closure.